Effects of Bacopa monnieri herbal supplement on aging and neurocognitive functions with relation to constitution (Prakriti) in healthy adults

ISRCTN	ISRCTN64126920
DOI	https://doi.org/10.1186/ISRCTN64126920
Secondary identifying numbers	University of Colombo Research Grant No. AP/3/2/2024/SG/10

Submission date: 22/01/2025
Registration date: 28/01/2025
Last edited: 13/03/2025

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Aging is an irreversible process influenced by both internal (genetic) and external (environmental) factors. These factors contribute to differences in how individuals age. Aging is not just about a decline in physical and mental abilities but involves complex biological mechanisms. Aging can be explained through two main theories: 1. Programmed Theories: Suggest that aging follows a biological clock; and, 2. Error Theories: Propose that aging is caused by environmental damage to cells, leading to DNA damage and the accumulation of harmful substances. One key factor in aging is telomere shortening. Telomeres are protective caps at the ends of chromosomes that shorten with each cell division. When they become too short, cells stop dividing, a process known as cellular senescence. Telomere length is maintained by an enzyme called telomerase, but its activity decreases with age. Aging is also associated with changes in the brain, including a decline in cognitive abilities like memory and decision-making. These changes can be observed through brain activity using techniques like EEG (electroencephalography). This study aims to explore whether an Ayurvedic herbal decoction can help slow aging-related changes, maintain telomere length, and improve cognitive functions.

Who can participate?
Healthy males and females aged 60 to 64 years with a Montreal Cognitive Assessment (MoCA) score of 24 or above

What does the study involve?
Participants will be randomly divided into two groups: one group will receive a herbal decoction (BMFD), and the other group will receive a placebo (a substance with no active ingredients). The study will last 90 days (45 days of treatment followed by 45 days of observation). Assessments will be conducted before treatment begins, after 45 days of treatment, and after 45 days of follow-up.

What are the possible benefits and risks of participating?
There are many possible benefits of being part of clinical research, including:
• Participants may have the chance to help the research group better understand their disease or condition and to advance treatments and ways to prevent it in the future.
• Participants may feel like playing a more active role in their health.
• Participants may learn more about their disease or condition.
• Participants may be able to get information about support groups and resources.
Compared with risk, the benefits are much less because the total study protocol assesses and screens the health status of the participants and it could lead to early detection of the cognitive impairment and total assessment of the health condition of the entire nerve system by nerve conduction test and electroencephalography.

These studies do come with some possible risks, including:
• The research may involve tests that pose a risk to participants. For example, certain physical tests (blood withdrawal) may increase the chance of contamination and physical discomfort.
• Participating in a study could also be inconvenient for participants for example may be required to have additional or longer medical appointments, more procedures, and complex investigation instructions, as given below would be followed in taking the measurements. Hematological and biochemical investigations will be assessed at baseline.

Where is the study run from?
The University of Colombo

When is the study starting and how long is it expected to run for?
May 2023 to April 2027

Who is funding the study?
The University of Colombo

Who is the main contact?
1. Dr H.L.N.R. Pradeep, Department of Basic Principles and Ayurveda Anatomy, Faculty of Indigenous Medicine, University of Colombo, ranganapradeep@fim.cmb.ac.lk
2. Prof Pathirage Kamal Perera, Faculty of Indigenous Medicine, University of Colombo, kamalperera@fim.cmb.ac.lk

Contact information

Dr Hewa Loku Nakathige Rangana Pradeep
Principal Investigator

Faculty of Indigenous Medicine
University of Colombo
Colombo
0094
Sri Lanka

ORCID ID	0009-0004-5186-5706
Phone	+94 (0)711723283
Email	ranganapradeep@fim.cmb.ac.lk

Prof Pathirage Kamal Perera
Public

Faculty of Indigenous Medicine
University of Colombo
Colombo
0094
Sri Lanka

ORCID ID	0000-0003-0337-1336
Phone	+94 (0)716419072
Email	kamalperera@fim.cmb.ac.lk

Prof Dilshani Dissanyake
Scientific

Department of Physiology
Faculty of Medicine
University of Colombo
Colombo
0094
Sri Lanka

ORCID ID	0000-0001-6859-2397
Phone	+94 (0)718232420
Email	dilshanid@physiol.cmb.ac.lk

Study information

Study design	Single-center parallel-assignment two-arm open-label non-inferiority randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Care home, Community, University/medical school/dental school
Study type	Quality of life, Treatment, Safety
Participant information sheet	46719_PIS.pdf
Scientific title	Influence of Bacopa monnieri on telomerase activity, telomere length and aging- related changes and cognitive functions with relation to prakriti (constitution) of healthy adults
Study acronym	BACOGENIC Study
Study hypothesis	The BMFD -Bacopa monnieri (L) Wettst freeze-dried decoction, dosage form, which demonstrates the highest anti-aging and anti-lipase activities, is hypothesized to be more effective in stabilizing the aging process and improving aging-related cognitive functions compared to a placebo.
Ethics approval(s)	Approved 16/11/2023, Ethics Review Committee Faculty of indigenous Medicine University of Colombo (ERCFIM) (Faculty of Indigenous Medicine University of Colombo, Colombo, +94, Sri Lanka; +94- 11-2692385 Ext- 112; ethicsreviewiim@gmail.com), ref: ERC 23/202
Condition	The healthcare domain being studied is healthy aging and cognitive function enhancement, with a focus on the influence of Bacopa monnieri (L) Wettst on telomerase activity, telomere length, and prakriti (constitution) of healthy adults.
Intervention	This will be a two-arm, open-label, non-inferiority randomized control trial in patients with cognitive impairment. A consecutive consenting sample method will be followed to select participants of the arms for the study. A blocked design will be used, using an online statistical computing web programming to generate the randomization schedule (research randomizer https://www.randomizer.org). Eligible subjects will be randomly assigned to Arm I and Arm II to receive herbal decoction (BMFD-Bacopa monnieri (L) Wettst freeze-dried decoction) and placebo. Participants will be informed to put the supplied herbal pack (60 g of BMFD) into a pot, add 1920 ml of water, and simmer under a low flame until the volume is reduced to 240 ml. The process of preparation under standard conditions will be demonstrated to patients who are selected for the BMFD Arm (Arm I) at the Neuroscience Research Centre, Department of Physiology, Faculty of Medicine, University of Colombo, Sri Lanka and Clinical trial Unit, Faculty of Indigenous Medicine, University of Colombo, Sri Lanka using a video. Consenting participants who meet the inclusion criteria undergo a general physical checkup by the PI. Participants with chronic and acute disorders will be excluded. Those selected for the study will be coded, and those undergoing Stage of BMFD dosage form or placebo (Arm II) will be given. The duration of the BMFD dosage form or placebo administration will be 45 days. It will be given as 120 ML twice a day. They will be requested to take a daily dose of 120 ml twice a day before meals. The total duration of BMFD administration is 45 days. Follow-up duration: 45 days.
Intervention type	Supplement
Primary outcome measure	The following primary outcome measures are assessed at baseline, 45 and 90 days: 1. Cognitive impairment will be measured using the Montreal Cognitive Assessment (MoCA) validated for the Sri Lankan population 2. Telomerase activity and telomerase length of blood mononuclear cells of participants measured using qualitative polymerase chain reaction (QPCR) 3. Median nerve and Ulnar for upper limb function and Tibial and Common peroneal nerve for lower limb function measured using the nerve conduction test (NCT) 4. Electrical activity of the brain measured using electroencephalography (EEG)
Secondary outcome measures	Health-related quality of life (HRQoL) measured using an HRQoL questionnaire (Janković, Slobodan M., et al. 2021) at baseline and the end of the intervention (after 45 days, 90 days of follow-up)
Overall study start date	11/05/2023
Overall study end date	18/04/2027

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	60 Years
Upper age limit	64 Years
Sex	Both
Target number of participants	37 patients for each arm
Participant inclusion criteria	Current inclusion criteria as of 13/03/2025: 1. Healthy individuals aged 60 - 64 years 2. Both males and females 3. Nonsmokers and non-alcoholic 4. The MoCA score is 24 or above Previous inclusion criteria: 1. Healthy individuals aged 60 - 64 years 2. Both males and females 3. Nonsmokers and non-alcoholic 4. The MoCA score ranges between 0-30 and a score of 24 or above
Participant exclusion criteria	1. Healthy individuals below 60 and above 64 2. Individuals between 60 to 64 years old with CKD, CVD, Liver disorders, psychiatric illnesses, DM, cancers, Hypertension, hyperlipidemia etc 3. Those who have medically diagnosed diseases with reduced capacity to answer questions
Recruitment start date	18/05/2025
Recruitment end date	18/11/2025

Locations

Countries of recruitment

Sri Lanka

Study participating centre

Neuroscience Research Center, Faculty of Medicine and Faculty of Indigenous Medicine, University of Colombo

The Faculty of Medicine and Faculty of Indigenous Medicine, University of Colombo
No. 25, Kynsey Road
Colombo
00800
Sri Lanka

Sponsor information

University of Colombo
University/education

College House
94, Cumaratunga Munidasa Mawatta
Colombo 03
Colombo
0094
Sri Lanka

Phone	+94 112 581 835
Email	dean@fim.cmb.ac.lk
Website	https://med.cmb.ac.lk/
"ROR"	https://ror.org/02phn5242

Funders

Funder type

University/education

University of Colombo
Government organisation / Local government

Alternative name(s): University of Colombo, Sri Lanka, UoC
Location: Sri Lanka

Results and Publications

Intention to publish date	30/12/2026
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer-reviewed journal. Additional documents will be available upon request from Dr H.L.N. Rangana Pradeep (ranganapradeep@fim.cmb.ac.lk). The study protocol is planned to be published in a peer-reviewed indexed journal.
IPD sharing plan	The datasets generated during and/or analyzed during the current study are/will be available upon request from Dr H.L.N. Rangana Pradeep (ranganapradeep@fim.cmb.ac.lk). Study participant data sheets will not include contact or identifying details. Study data entry and study management systems used by clinical sites will be secured and password protected. At the end of the study, all study databases will be de-identified and archived. The availability of raw data for the study is based on the above conditions.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			24/01/2025	No	Yes

Additional files

46719_PIS.pdf

Editorial Notes

15/03/2025: The public title was updated from 'Effects of Bacopa monnieri herbal supplement on aging, cognitive function, and constitution (Prakriti) in healthy adults' to 'Effects of Bacopa monnieri herbal supplement on aging and neurocognitive functions with relation to constitution (Prakriti) in healthy adults'. The inclusion criteria were updated.
24/01/2025: Study existence confirmed by the Ethics Review Committee Faculty of Indigenous Medicine University of Colombo (ERCFIM).